Alivamab Discovery Services LLC, of San Diego, disclosed a multitarget discovery agreement with Janssen Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, under which it will provide its Alivamab Mouse antibody discovery platform to generate and deliver candidates to Janssen for further evaluation. Financial terms were not disclosed.
Amplyx Pharmaceuticals Inc., of San Diego, said it executed an exclusive worldwide license agreement with Basel, Switzerland-based Novartis AG to acquire the rights to the phase II anti-BK virus (BKV) monoclonal antibody, MAU-868, for the treatment and prevention of BKV disease. BKV reactivation can occur following kidney transplantation and may result in BKV nephropathy, a leading cause of renal allograft loss. It also occurs in patients who have received hematopoietic stem cell transplants and can lead to hemorrhagic cystitis. The company is planning two phase II proof-of-concept trials of MAU-868 in BKV disease. Financial terms of the transaction have not been disclosed.
Batavia Biosciences BV, of Leiden, the Netherlands, said it received a grant of $6.5 million from the Bill & Melinda Gates Foundation to develop a manufacturing process for an oral vaccine against polio virus type 2 strain to help protect children worldwide from future polio outbreaks.
Benitec Biopharma Ltd., of Melbourne, Australia, said it plans to complete three BB-301 nonclinical studies that will facilitate the filing of an IND and the formal initiation of a phase I trial in patients suffering from oculopharyngeal muscular dystrophy (OPMD). The product is an internally optimized, AAV-based gene therapy agent that offers the potential to restore the underlying physiology of the treated tissues and, in the process, improve treatment outcomes for patients with OPMD. The studies, conducted in canine subjects, will support the optimization of the methods of administration, confirm the efficiency of vector transduction in the key tissue compartments underlying the disease phenotype, confirm the optimal drug doses in advance of initiation of human clinical studies, and finalize experiments designed to characterize any toxicological data points that would underlie future regulatory filings and clinical study designs.
Context Therapeutics Inc., of Philadelphia, and Solti, an academic group in Barcelona, Spain, agreed to collaborate on a window of opportunity study in the neoadjuvant setting for breast cancer. During the Onawa study, patients will receive oral doses of progesterone receptor antagonist Apristor (onapristone ER) and will be biopsied on day one, followed by treatment and a final biopsy after three weeks, on the day of their full lumpectomy or mastectomy. Data generated are intended to confirm the recommended phase II dose.
Innovation Pharmaceuticals Inc., of Beverly, Mass., said formulation partner BDD Pharma performed nonclinical studies showing the oral dosage form of brilacidin meets in vitro specifications for selective delivery to the colon. The first oral trial of brilacidin in the company's ulcerative colitis program is expected to start in healthy volunteers in the U.K. in December.
Karyopharm Therapeutics Inc., of Newton, Mass., said it entered a royalty agreement with Healthcare Royalty Partners (HCR) for up to $150 million to support ongoing development and commercialization of Xpovio (selinexor), its oral SINE compound, approved in July in the U.S. for heavily pretreated multiple myeloma patients. Under the terms, Karyopharm will receive $75 million at closing this month and is eligible to receive an additional $75 million upon achievement of future regulatory and commercial milestones and subject to approval by both parties. In exchange for the amount received at initial closing, HCR will receive a tiered royalty in the mid-single digits based on worldwide net revenues of Xpovio and any other future products. Karyopharm said it expects the initial $75 million, combined with its existing cash, cash equivalents and investments, together with the cash expected to be generated from product sales, will be sufficient to fund its operations into the middle of 2021. (See BioWorld, July 5, 2019.)
Oncoheroes Biosciences Inc., of Boston, and Boehringer Ingelheim International GmbH. of Ingelheim, Germany, reached an exclusive licensing agreement for volasertib, an investigational cancer compound to treat pediatric cancers. Oncoheroes has worldwide rights to research, develop, sell and sublicense volasertib. The compound, discovered and developed by Boehringer, is an inhibitor of Polo-like kinase, an enzyme involved in cancer progression in a number of diseases. None of the deal's financial details were released. In June 2016, Boehringer's phase III study of volasertib plus chemotherapy for treating elderly acute myeloid leukemia failed to meet its primary endpoint.
Sanofi SA, of Paris, and Abbott Park, Ill.-based Abbott Laboratories plan to integrate glucose sensing and insulin-delivery technologies to develop smart pens, insulin titration apps and cloud software. The companies' nonexclusive agreement initially enables data-sharing between Sanofi's insulin pens, apps and cloud software with Abbott's Freestyle Libre mobile app and cloud software. No financial details were released.
Tarsius Pharma Ltd., of Tel-Aviv, Israel, was awarded a $2.6 million Horizon 2020 grant from the European Commission to begin clinical development of TRS, Tarsius' platform for treating autoimmune and inflammatory ocular diseases. Tarsius was created in 2016, and Horizon 2020 is part of the EU's Research and Innovation program, which has awarded $88 billion of funding since 2014.
Tonix Pharmaceuticals Holding Corp., of New York, said TNX-1600, an orally active triple monoamine reuptake inhibitor, displayed antidepressant and anti-post-traumatic stress disorder effects in rats, compared to paroxetine, a selective serotonin reuptake inhibitor. The study concluded that TNX-1600 could reduce maladaptive retention of fearful memories, and it was effective in animal models without affecting locomotor activity. The research paper appeared in the European Journal of Pharmacology.